SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

Alamycin LA 200 mg/ml solution for injection

2. Qualitative and Quantitative Composition

Active Substance:

Oxytetracycline Dihydrate 21.6% w/v (Equivalent to Oxytetracycline 20.0% w/v)

Excipients:

Sodium Formaldehyde Sulphoxylate Dihydrate (0.4%w/v)

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Solution for injection.

A clear amber solution.

4. Clinical Particulars

4.1 Target species

Cattle, sheep and pigs.

4.2 Indications for use, specifying the target species

The product is indicated for use in cattle, sheep and pigs in the treatment of:

- Atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.

- Navel/joint ill caused by Arcanobacterium pyogenes, E. coli or Staphylococcus aureus.

- Mastits caused by Corynebacterium pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiaeor Streptococcus uberis.

- Metritis caused by E. coli or Streptococcus pyogenes.

- Pasteurellosis and infections of the respiratory tract caused by Mannheimia haemolytica and Pasteurella multocida.

- Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.

- Erysipelas caused by Erysipelothrix rhusiopathiae.

The product can also be used in the control of enzootic abortion in sheep.

4.3 Contraindications

Not for use in horses, dogs, cats.

Not for use in animals suffering from hepatic or renal damage.

4.4 Special Warnings for Each Target Species

No special warnings.

4.5 Special Precautions for Use

i. Special Precautions for use in animals

Do not dilute the product.

If concurrent treatment is administered, use a separate injection site.

ii. Special precautions to be taken by the person administering the product to the animals

Wash hands after use. In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.

Take care to avoid accidental injection

4.6 Adverse reactions (frequency and seriousness)

Although the product is well tolerated, occasionally a slight local reaction of a transient nature has been observed.

4.7 Use during pregnancy, lactation or lay

The use of oxytetracycline during the period of tooth and bone development, including late pregnancy may lead to tooth discoloration, the product can be safely administered to lactating animals.

4.8 Interactions with other medicinal products and other forms of interaction

None known.

4.9 Amount to be administered and administration route

The recommended dose rate is 20 mg/kg bodyweight (i.e. 1 ml per 10 kg bodyweight) administered by deep intramuscular injection. The product is recommended for a single administration only.

Maximum recommended dose at any one site:

Cattle : 20ml

Pigs : 10ml

Sheep : 5ml

Piglets: 1 day 0.2ml

7 days 0.3ml

14 days 0.4ml

21 days 0.5ml

Over 21 days 1.0 ml/10kg.

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)

There is no known specific antidote, if signs of possible overdose occur, treat the animal symptomatically.

4.11 Withdrawal periods

Cattle: Meat – 31 days

Milk – 10 days

Sheep: Meat – 9 days

Milk – 7 days

Pigs: Meat – 18 days

5. Pharmacological Properties

Pharmacotherapeutic group: Antibiotic

ATCvet Code: QJ01AA06

5.1 Pharmacodynamic properties

Oxytetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside the cell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of amino acids to the elongating peptide chain, inhibiting protein synthesis. The product is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity.

Oxytetracycline had been shown to be effective in vitro against the following bacterial species: Bordetella bronchiseptica, Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.

5.2 Pharmacokinetic properties

Blood levels persist for at least 4 days after administration by the intramuscular route. Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.

6. Pharmaceutical Particulars

Sodium formaldehyde sulphoxylate dihydrate

Magnesium Oxide Light

Dimethylacetamide

Disodium Edetate Dihydrate

Ethanolamine

Water for Injections

6.2 Incompatibilities

None Known.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

Do not store above 25ºC. Protect from light.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material

When the vial has been broached and contents exposed to air, the solution may darken but the potency will be unchanged.

6.5 Nature and composition of immediate packaging

Amber type I or II glass vials of 50 ml and 100 ml sealed with Bromobutyl Rubber Bungs and aluminium overseals.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

NEWRY

Co. Down, BT35 6JP

Northern Ireland

8. Marketing Authorisation Number

Vm 02000/4117

9. Date of First Authorisation/Renewal of the Authorisation

Date: 20^th October 1993/20^th October 2003

10. Date of Revision of the Text

Date: November 2011